Telemedicine or Standard Care in Treating Patients With Depression and/or Pain Caused By Cancer

September 19, 2013 updated by: Indiana University Melvin and Bren Simon Cancer Center

TeleCare Management of Pain and Depression in Cancer

RATIONALE: Telemedicine may help in the treatment of depression and/or pain caused by cancer. It is not yet known whether telemedicine is more effective than standard care in treating depression and/or pain caused by cancer.

PURPOSE: This phase III randomized clinical trial is studying telemedicine to see how well it works compared to standard care in treating patients with depression and/or pain caused by cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Compare the effectiveness of a state-wide, telemedicine intervention with standard care in cancer patients with clinical depression and/or cancer-related pain.
  • Compare improvement in clinical depression and/or cancer-related pain in patients undergoing these interventions.

Secondary

  • Compare health-related quality of life, functional status, and patient satisfaction with treatment in patients undergoing these interventions.
  • Compare the economic benefits of these interventions in these patients.

OUTLINE: This is a randomized, longitudinal, multicenter study. Patients are stratified according to study site and type of symptom (pain only vs depression only vs pain and depression). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (standard care): Patients receive treatment for pain, depression, and other symptoms from their oncologist.
  • Arm II (telemedicine intervention): Patients undergo automated, home-based symptom monitoring either by telephone or the Internet, depending on preference, coupled with telephonic care management by a clinical specialist. Patients complete questionnaires via the Internet or undergo standardized interviews via telephone measuring depression, pain, quality of life, and other patient-reported variables twice weekly for approximately 1 month, once weekly for 2 months, twice a month for 3 months, and then once a month for 6 months. A clinical specialist trained in treating the symptoms of pain and depression also contacts the patient by phone to assess symptom severity and initiate treatment. A follow-up call is made at 1-2 weeks to assess symptom severity, adherence, and adverse effects. Patients with depression receive 2 additional follow-up calls in the first 12 weeks. The clinical specialist also calls the patient when automated monitoring indicates inadequate symptom improvement or side effects, or the patient requests to be contacted. The clinical specialist works with the patient's regular doctor in adjusting medicines and treatment for symptoms as needed. Patients who do not complete their scheduled assessments receive an automated call or e-mail message reminding them to complete the symptoms questionnaires. Patients who do not respond to this reminder within 24 hours are contacted by the clinical specialist.

In both arms, patients are interviewed at baseline, 1, 3, 6, and 12 months. Patients are asked questions about pain, depression, other physical and emotional symptoms, work activities, quality of life, and satisfaction with treatment.

PROJECTED ACCRUAL: A total of 480 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Anderson, Indiana, United States, 46011
        • Community Cancer Center at Community Hospital of Anderson
      • Bedford, Indiana, United States, 47421
        • Community Cancer Care at Bedford Oncology Specialty Clinic
      • Columbus, Indiana, United States, 47201
        • Columbus Regional Hospital Cancer Center
      • Greencastle, Indiana, United States, 46135
        • Community Cancer Care at Putnam County Hospital
      • Greensburg, Indiana, United States, 47240
        • Community Cancer Care at Decatur County Hospital
      • Indianapolis, Indiana, United States, 46202
        • William N. Wishard Memorial Hospital
      • Indianapolis, Indiana, United States, 46206-1367
        • Methodist Cancer Center at Methodist Hospital
      • Indianapolis, Indiana, United States, 46219
        • Community Regional Cancer Care at Community Hospital East
      • Indianapolis, Indiana, United States, 46256
        • Community Regional Cancer Care at Community Hospital North
      • Indianapolis, Indiana, United States, 46202
        • Veterans Affairs Medical Center - Indianapolis
      • Indianapolis, Indiana, United States, 46202-2872
        • Regenstrief Institute, Incorporated
      • Indianapolis, Indiana, United States, 46202
        • Community Cancer Care
      • Kokomo, Indiana, United States, 46902
        • Community Cancer Care at Howard Regional Health System
      • Madison, Indiana, United States, 47250
        • Community Cancer Care at King's Daughters' Hospital
      • Seymour, Indiana, United States, 47274
        • Schneck Medical Center
      • Tell City, Indiana, United States, 47586
        • Community Cancer Care at Perry County Hospital
      • Tipton, Indiana, United States, 46072
        • Community Cancer Care at Tipton County Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer AND 1 or both of the following:

    • Clinical depression

      • Depression must be of at least moderate severity (PHQ-9 score ≥ 10)

        • Depressed mood and/or anhedonia endorsed
      • No depression directly precipitated by cancer therapy for which depression is a well known side effect (e.g., interferon, corticosteroids)

    • Cancer-related pain

      • Pain must be at least moderate in severity (Brief Pain Inventory score ≥ 6), persisted despite using ≥ 2 analgesics, and cancer-related
      • If the only pain is due to a pre-existing condition (e.g., migraine, headache, arthritis, etc), the patient may not be eligible

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 6 months
  • Must speak English
  • Not pregnant
  • Fertile patients must use effective contraception
  • No moderately severe cognitive impairment
  • No schizophrenia or other psychosis
  • No disability claim currently being adjudicated for pain

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Not in hospice care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure
Health-related quality of life at baseline and 1, 3, 6, and 12 months
Cost-effectiveness of care at baseline and 1, 3, 6, and 12 months
Treatment satisfaction at baseline and 1, 3, 6, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University Melvin and Bren Simon Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Kurt Kroenke, MD, Regenstrief Institute, Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

April 11, 2006

First Submitted That Met QC Criteria

April 11, 2006

First Posted (Estimate)

April 12, 2006

Study Record Updates

Last Update Posted (Estimate)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 19, 2013

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000466348
  • IUMC-051009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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